MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 49/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018956
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced an infection.This adverse event was treated with a revision surgery on (b)(6) 2022, in which a polarcup xlpe insert 49/28 non-cem was explanted.Moreover, a knee fusion fan l 11.5mm x 75cm along two (2) trigen low profile screw 5.0mm x 27.5mm were used as an antibiotic spacer, and a temporary implant was used to counteract infection.Patient is currently hospitalized overcoming previous infection.
Additional Manufacturer Narrative
Internal complaint reference: case- (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced an infection.This adverse event was treated with a revision surgery on (b)(6) 2022.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.A review of the batch record, including the sterilization certificate revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.The ifu (lit.No.12.23 ed 03/21) lists infection as a known possible adverse effect resulting from a hip arthroplasty.A medical investigation was conducted.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.Based on the performed investigation, the reported failure mode cannot be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Internal complaint reference: (b)(4).

• Brand Name: POLARCUP XLPE INSERT 49/28 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13938826
• Report Number: 9613369-2022-00065
• Device Sequence Number: 4791982
• Product Code: LPH
• UDI-Device Identifier: 07611996111460
• UDI-Public: 07611996111460
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75018956
• Device Catalogue Number: 75018956
• Device Lot Number: B2124789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KNEE FUSION FAN L 11.5MM X 75CM-20GM16891; TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM-16FM03707; TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM-16LM10522
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown